| CTRI Number |
CTRI/2025/09/094475 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two medicines letrozole and mifepristone used before misoprostol for the treatment of abortion |
|
Scientific Title of Study
|
Randomized controlled trial comparing letrozole versus mifepristone for pretreatment in medical management of first trimester missed abortion |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| bandana1994 |
ClinicalTrials.gov |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VANDANA DEVI |
| Designation |
secodary dnb pg resident |
| Affiliation |
Baba Saheb Ambedkar hospital Rohini new Delhi |
| Address |
Room no 279
Room no 279 hospital campus
North West
DELHI
110085
India |
| Phone |
07879533029 |
| Fax |
|
| Email |
bandanapcms2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Sharma |
| Designation |
Senior Specialist and professor |
| Affiliation |
Baba Saheb Ambedkar Hospital Rohini new Delhi |
| Address |
Hospital campus
Room no 279 hospital campus
North West
DELHI
110085
India |
| Phone |
09560653463 |
| Fax |
|
| Email |
sneeraj90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Khatri |
| Designation |
M.S. OBGY Specialist and professor |
| Affiliation |
Baba Saheb Ambedkar Hospital Rohini new Delhi |
| Address |
Room number 280 hospital campus
Room number 280 hospital campus
North West
DELHI
110085
India |
| Phone |
8130940185 |
| Fax |
|
| Email |
aassingh111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baba Saheb Ambedkar hospital Rohini new Delhi India pincode 110085 |
|
|
Primary Sponsor
|
| Name |
Dr Vandana Devi |
| Address |
Room no 279 type 1
Baba Saheb Ambedkar hospital Rohini new Delhi India pincode 110085 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Devi |
Labor room first floor gynecology department north west DELHI |
Baba Saheb Ambedkar hospital and medical college pincode 110085 india
North West
DELHI |
09399150645
bandanapcms2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Baba Saheb Ambedkar hospital and medical callege new delhi 110085 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O034||Incomplete spontaneous abortion without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Letrozol |
group 1 patient will take an oral dose of letrozole 10 mg once daily for three consecutive days in ward. On the morning of third dose. they will receive 800 mcg of vaginal misoprostol in the labor room after clinical examination |
| Comparator Agent |
mifepristone |
Patients will receive a single oral dose 200 mg of mifepristone in the ward after 48 hours, they will receive 800 mcg of vaginal misoprostol, administered by a doctor in the labor room Total duration of study 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Hemodynamically stable patient
2.Gestational age up to 12 complete weeks of gestation by LMP and missed - abortion confirmed by following USG criteria [USG findings CRL more than 7mm and no heartbeat or mean sac diameter (MSD) more than 25 mm no embryo visualized]
Hb 9 g/dl,
|
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to letrozole or misoprostol, mifepristone
2.Known case of heart, liver, kidney disease and adrenal insufficiency
3.History of bleeding disorder or intake of anticoagulant drug
4.History of previous 2 LSCS or more, history of myomectomy or other uterine surgery
5.Diagnosed case of uterine fibroid, uterine anomalies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
9.To determine the efficacy of letrozole versus mifepristone as a pretreatment in management of first trimester missed abortion in terms of
Induction to expulsion interval
need for surgical interventions
|
baseline follow by 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the following complications and side effects in both the groups
a Abnormal uterine bleeding
b Pain abdomen
Retained product of conception after day 14
|
14 days after expulsion |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recent studies suggest that letrozole may enhance effectiveness of misoprostol in medical abortion the exploration of letrozole as a pretreatment agent before misoprostol administration present a promising alternative in medical management of first trimester missed abortion especially setting where mifepristone is contraindicated moreover letrozole can be cheaper than mifepristone |